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2School of Medicine, Health Policy and Practice, University of East Anglia, Norwich NR4 7TJ

Correspondence to: A Barrett ann.barrett{at}uea.ac.uk

Accepted 11 October 2006

New guidance from the National Institute for Health and Clinical Excellence recommends Herceptin in early breast cancer, but it provides no additional funding or any suggestion of which services to cut. This leaves medical staff with difficult decisions to make

In the United Kingdom the “value for money” of new medical technologies is formally assessed through the National Institute for Health and Clinical Excellence (NICE), which commissions cost effectiveness analyses. These analyses are summarised in terms of cost per quality adjusted life year. Services with a cost per quality adjusted life year less than £30 000 are usually viewed as good value for money, and NICE will recommend their adoption by the National Health Service.12

The debate over trastuzumab (Herceptin) in early breast cancer has highlighted a major deficiency in the system—although NICE now recommends adopting this new technology, it provides no extra funding and does not suggest what cuts should be made to release these extra funds.3 We outline how the cost of giving Herceptin should not be measured in money alone, but also in the treatments that will have to be dropped to balance the books.

The Herceptin debate

Herceptin is a monoclonal antibody against the HER2 protein that is overexpressed in 20-25% of patients with breast cancer. For palliation and in certain other clinical circumstances, NICE recommended its use in women whose tumours have high (3+) expression of the HER2 receptor.4 The NICE appraisal of Herceptin as adjuvant treatment has just been released, and the National Cancer Research Institute has also issued clinical guidelines.35

Readers will be aware of the heated debate surrounding this treatment.67 The media have made little mention of the restricted categories of patients for whom Herceptin may be appropriate, or of the lack of long term toxicity data, especially concerning effects on the heart. Although the three published trials showed a statistically significant improvement in rates of recurrence, as yet, only one has shown a benefit in survival (4.8% at four years).8910 Despite the lack of NICE approval at the time, several patients obtained Herceptin through their local NHS by appealing to the courts.11 NICE promised to “fast track” Herceptin, and it is no surprise that the resulting guidance is positive.12

This means that our trust (Norfolk and Norwich University Hospital) will have to find £1.9m (€2.9m; $3.6m) each year in drug costs alone to make Herceptin available to the 75 patients who may be eligible. This becomes £2.3m if the costs of pathology testing, cardiac monitoring, pharmacy preparation, and drug administration are added. On the face of it, the answer to our question is simple—Herceptin will cost our trust £2.3m—but the real cost lies in the services that will be cut to provide this money. This is an important element currently missing from the debate.

Cost effectiveness comparison

To illustrate this, we audited drug costs in the oncology centre of our hospital. We then hypothesised how we could save £1.9m by cutting curative and palliative chemotherapy treatments (tables 11 and 2⇓).

Table 1

Cost and potential benefits of adjuvant cancer treatments in Norfolk and Norwich University Hospital Trust

The sum of £1.9m would enable us to treat 75 patients with Herceptin, but at four times the cost of the adjuvant treatments shown in table 1⇑. These treatments have been proved to be clinically effective and their estimated cost effectiveness is far greater than that currently expected for Herceptin. The cost of giving adjuvant Herceptin is double that of all the palliative treatments shown in table 2⇑.

So we could fund Herceptin if we did not treat 355 patients receiving adjuvant treatment (16 of whom would be cured) or 208 patients receiving palliative chemotherapy, and if we found £0.5m from another source. These untreated patients will be people we know. We will be the ones to tell them they are not getting a treatment that has been proved to be effective, which costs relatively little, because it is not the “treatment of the moment.”

Summary points

Guidance from the National Institute for Health and Clinical Excellence on new treatments does not have additional funding attached, and does not recommend which services should be cut to pay for new treatments

NICE should be given responsibility to decide what should be cut to fund newly recommended technologies or the ability to allocate extra funds for implementation, or both

These results are obviously not definitive, but illustrate the fundamental challenge facing the NHS—the tension between national priority setting and local implementation.13 Currently central government allocates the overall NHS budget to primary care trusts and other substructures. Local bodies, such as primary care trusts, then divide these funds between primary and secondary care, treatment, and prevention, etc.14 The situation is more complex for long term treatments (such as Herceptin), which—under practice based commissioning—fall on primary care budgets rather than hospitals. Although in practice this means that Herceptin may eventually be vying with other clinical areas, such as paediatrics or orthopaedic surgery, it does not affect the central message of our example here—that the real cost of Herceptin is in the other patients not treated, whether they are patients with cancer or those with other conditions. NICE gives no guidance on this issue. The current situation with Herceptin highlights our central argument—that as NICE guidance provides no extra funding or suggestions of which services to cut, medical professionals ultimately have to make these difficult decisions.

A further complicating factor, well illustrated by Herceptin but seen in many other cases, is the susceptibility of these decisions to external pressures.1516 The relative media and public appeal of “sexy” versus “Cinderella” services and the power of different clinical specialties have always exerted external pressure on allocation of resources in the NHS (and other healthcare systems).17 In the case of Herceptin, high profile patients, media bias, industry support, and political gaming put considerable pressure on the NHS to offer this drug in early stage breast cancer. NICE's decision highlights the “rubber stamping” role that this government appointed body seems to have adopted, and that in priority setting NICE's bark is much worse than its bite.18

Their decision is understandable as an appeal to the emotional principle of “rule of rescue” (the imperative people feel to rescue identified individuals facing avoidable death).19 When new technologies (such as Herceptin) arise, it is relatively easy to pit the known patient in need against either the system in general or a set of “anonymous” patients elsewhere. Priority setting tends to be focused at this “anonymous” level.20 But no patient is anonymous, especially not to the attending doctor who also has the ultimate rationing responsibility in the current system. We have deliberately not discussed priority setting between Herceptin and, for example, neonatal intensive care or hip replacements. We think that it is important to focus, for a change, on the “clinical coal face” as this is the ultimate reality. We, not NICE, have to choose which other treatments will not be provided and which of our patients will not be treated.

Nobody has suggested what treatments we cut in favour of Herceptin—not the media, medical advocates of the drug, the courts who upheld patient appeals, or NICE. It would be especially interesting to know what the secretary of state for health would like us to cut.

Political pressure, patient advocacy, and media hyperbole should not determine who is treated and what they are treated with. NICE is an established system, but it currently creates more problems than solutions. This organisation must be given responsibility to decide what should be cut to fund newly recommended technologies or the ability to allocate extra funds for implementation (or both). Without these changes Herceptin will not be the last controversial case of “rationing by media.”

Footnotes

Extra references w1-w14 are on bmj.com

Contributors and sources: AB has more than 130 publications across paediatric and psychosocial oncology and radiotherapy health service issues. RS has more than 100 publications covering aspects of health service reform, the valuation of health benefits, and globalisation and health policy. Main sources of information were the websites of Cancer Research UK and National Institute for Health and Clinical Excellence and electronic databases of the department of oncology, Norfolk and Norwich University Hospital NHS Trust. AB and RS had the original idea for the article. All authors helped write the article. AB is guarantor.

Breast Clinical Studies Group. UK clinical guidelines for the use of adjuvant trastuzumab (Herceptin®) with or following chemotherapy in HER2-positive early breast cancer. London: National Cancer Research Institute, 2005. www.dh.gov.uk/assetRoot/04/12/63/84/04126384.pdf.